Regulatory Science in a Changing Landscape for Device Trials

September 06, 2025 | 08:00 AM (EDT) - 08:45 AM (EDT)

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Speakers
Avi Fischer, MD, FHRS
Senior Vice President, Medical Affairs and Innovation
Orchestra BioMed, Inc.
Ishu Rao, MD
Medical Director & Senior Vice President of Medical Affairs
Impulse Dynamics
Leyla Sabet
Director, Product Development - Cardiac Rhythm Management
Abbott
Moderator
Adrian Hernandez
Executive Director | Vice Dean
Duke Clinical Research Institute | Duke University School of Medicine

Regulatory Science in a Changing Landscape for Device Trials

Innovation Stage
September 06, 2025 | 08:00 AM (EDT) - 08:45 AM (EDT)

This session will highlight the challenges, current best practices, and how innovation will impact regulatory science, with a focus on first-in-human device trials. The session will highlight shared and unique challenges in different regions of the world, including Asia, Europe, and North America. Attendees will be armed with a better understanding of the key barriers and facilitators for successful first-in-human trials.